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Clinical Trials/CTRI/2022/11/046962
CTRI/2022/11/046962
Completed
Phase 3

An interventional study to assess the effectiveness of single perineural injection of platelet rich plasma on nerve function with special emphasis on nerve function of Hansens disease with truncal (mixed) neuropathy

AIIMS Bhopal0 sites30 target enrollmentTBD

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: A309- Leprosy, unspecified
Sponsor
AIIMS Bhopal
Enrollment
30
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
December 30, 2022
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Known case of Hansen’s disease on or post treatment with Multi drug therapy
  • 2\. Age: \=18 years
  • 3\. Patients of Hansen’s disease with peripheral neuropathy involving Ulnar and/ or
  • Common Peroneal Nerve with residual impairment
  • 4\. Willingness to participate in study (informed written consent)
  • 5\. Willingness to forego any other concomitant treatment modality

Exclusion Criteria

  • 1\. Hansen’s disease diagnosed for more than three years duration.
  • 2\. Signs of active inflammation or abscess around the Ulnar or Common Peroneal
  • 3\. Diagnosed case of active lepra reaction
  • 4\. Infection at the site of injection
  • 5\. Reduced range of motion of knee, elbow, wrist or ankle
  • 6\. Abnormal radiograph of elbow joint and knee joint of the affected side
  • 7\. Received local steroid injection within 6 months, NSAIDS within one week prior
  • to intervention or on systemic steroids more than 20 mg daily
  • 8\. Abnormal haemoglobin or blood count (platelet count \< 50x 109
  • g/dl,Mean platelet volume \>12\.3 fl)

Outcomes

Primary Outcomes

Not specified

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